Study: Diabetes drug lowers amputation risk

[May 22, 2009]  LONDON (AP) -- Doctors who gave diabetics a drug originally intended to lower patients' cholesterol found it reduced their risk of so-called minor amputation by 36 percent, a new analysis of research says. Researchers in Australia, Finland and New Zealand studied almost 10,000 patients aged 50 to 75 with type 2 diabetes, the kind linked to obesity.

About half of the patients were given fenofibrate, a drug available generically and sold as Antara, Fenoglide, Lipofen and others. The other half got fake pills. After five years, 115 patients had at least one lower limb amputation because of diabetes.

Diabetes can damage nerves and blood vessels. In severe cases, this leads to amputation. About one diabetes patient in 10 loses part of a leg.

The study, first published in 2005, aimed to see if fenofibrate prevented heart disease. It didn't.

But in this new analysis, experts found patients on fenofibrate had a 36 percent lower risk of a first amputation than those on placebo.

Patients who lost part of their legs were more likely to have heart disease, smoking, skin ulcers or previous amputations. Amputations were labeled minor if they were below the ankle and major if they were above the ankle.

The risk of minor amputations in patients without large vessel disease, the narrowing of blood vessels, was nearly 50 percent lower in the group taking fenofibrates. The risk of a major amputation was not substantially different between the two groups. Taller people were also more likely to suffer amputations.

The results were published Friday in the medical journal Lancet. The study was paid for by Laboratoires Fournier SA, now part of Solvay Pharmaceuticals, which makes fenofibrates, and the National Health and Medical Research Council of Australia.

After the study's first results, many doctors switched to statins to cut their patients' heart disease risks and dropped fenofibrates.

"Fenofibrates may be re-entering the game," said Sergio Fazio of Vanderbilt University Medical Center, who co-authored an accompanying commentary in the Lancet. "Fenofibrates cannot possibly take the place of statins, but they may earn a place next to them in diabetes treatment."

The study's authors said their findings could change the standard treatment for avoiding amputations.

"(Fenofibrates) is the first therapy that has been shown to reduce these amputations," said Anthony Keech of the Royal Melbourne Hospital in Australia and one of the paper's authors.

Victoria King of the charity Diabetes UK said the study could help doctors find more ways of reducing diabetes-related amputations.

Fenofibrates can cause side effects including abdominal pain, nausea, pancreas and lung problems.

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On the Net:

http://www.lancet.com/

[Associated Press; By MARIA CHENG]

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